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Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

ABSTRACT: INTRODUCTION:Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. METHODS AND ANALYSIS:This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. ETHICS AND DISSEMINATION:This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. TRIAL REGISTRATION NUMBER:NCT02921932 (ClinicalTrials.gov).

SUBMITTER: Abdullah HR

PROVIDER: S-EPMC5629626 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

Abdullah Hairil Rizal HR Lien Victoria Peixin VP Ong Hwee Kuan HK Er Pei Ling PL Hao Ying Y Khan Shariq Ali SA Liu Christopher Weiyang CW

BMJ open 20170804 8

<h4>Introduction</h4>Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of fra ...[more]

PMID: 28778994

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Project description:In this study, we performed a retrospective and prospective study of preoperative predictors of the length of stay (LOS) in three groups of surgical patients and conducted a clinical retrospective study of the current research status of preoperative predictors of LOS prolongation in three groups of patients under ERAS (enhanced recovery after surgery) mode, such as patient characteristics and comorbidities. Information such as patients' exercise preferences, exercise time, frequency and duration, footwear, location of knee osteoarthritis, whether there is a past history of knee injury, and smoking and drinking history was collected, and the research data of 312 patients undergoing the three operations were analyzed by SPSS. Meniscal injury-knee arthroscopy sample included a total of 104 people. Surgical sample for anterior cruciate ligament reconstruction included a total of 100 subjects. Knee osteoarthritis-knee replacement surgery sample included 148 people who were divided into two groups in a ratio of 1 : 1: one group used Mailuo Shutong pills during hospitalization (intervention group) and the other group did not (control group). The research conclusions are as follows. Meniscal Knee Arthroscopy. (1) Samples from different causes of injury showed significant differences for all injured sites. (2) Samples with different smoking and drinking histories all showed significant differences for the causes of injury. (3) Exercise hobby, exercise frequency, duration of each exercise and duration of exercise, and warm-up time before exercise all showed positive correlation. Anterior Cruciate Ligament Reconstruction Surgery. (4) Samples from different causes of injury showed significant differences for all the injured sites. (5) Age has a significant negative influence on the wearing of shoes at ordinary times. (6) Exercise hobby: the warm-up time before exercise had a significant negative influence on the injured area. (7) Two groups of analysis items of exercise frequency, exercise duration and exercise duration, preexercise warm-up time, and exercise hobby were typically positively correlated. Total Knee Arthroplasty. (8) There was a significant difference of 0.01 between the hospitalization days of the intervention group and the control group (p < 0.01), and the hospitalization days of the intervention group were significantly lower than those of the control group. These results indicated that Mailuo Shutong pills were of great significance for the treatment of orthopedic patients during the operation period in that it could effectively shorten the hospital stay of all orthopedic patients and strengthen the accelerated rehabilitation. (9) There was a significant positive correlation between the history of knee joint surgery and the use time of Mailuo Shutong pills. (10) There was a markable positive correlation between occupation and sports hobbies, sports time, frequency and duration, and footwear. There was a significant negative correlation between occupation and preexercise warm-up. (11) Exercise time, frequency, and duration have significant positive influence on BMI.

Project description:INTRODUCTION:Preoperative anemia and old age are independent risk factors for perioperative morbidity and mortality. However, despite the high prevalence of anemia in elderly surgical patients, there is limited understanding of the impact of anemia on postoperative complications and postdischarge quality of life in the elderly. This study aims to investigate how anemia impacts elderly patients undergoing major abdominal surgery in terms of perioperative morbidity, mortality and quality of life for 6 months postoperatively. METHODS AND ANALYSIS:We will conduct a prospective observational study over 12 months of 382 consecutive patients above 65 years old, who are undergoing elective major abdominal surgery in Singapore General Hospital (SGH), a tertiary public hospital. Baseline clinical assessment including full blood count and iron studies will be done within 1 month before surgery. Our primary outcome is presence of morbidity at fifth postoperative day (POD) as defined by the postoperative morbidity survey (POMS). Secondary outcomes will include 30-day trend of POMS complications, morbidity defined by Clavien Dindo Classification system (CDC) and Comprehensive Complication Index (CCI), 6-month mortality, blood transfusion requirements, days alive out of hospital (DaOH), length of index hospital stay, 6-month readmission rates and Health Related Quality of Life (HRQoL). HRQoL will be assessed using EuroQol five-dimensional instrument (EQ-5D) scores at preoperative consult and at 1, 3, and 6 months. ETHICS AND DISSEMINATION:The SingHealth Centralised Institutional Review Board (CIRB Ref: 2017/2640) approved this study and consent will be obtained from all participants. This study is funded by the National Medical Research Council, Singapore (HNIG16Dec003) and the findings will be published in peer-reviewed journals and presented at academic conferences. Deidentified data will be made available from Dryad Repository upon publication of the results.

Project description:BackgroundPostoperative pulmonary complications (PPCs) have an impact on the recovery of adults after surgery. It is therefore important to establish whether preoperative respiratory rehabilitation can decrease the risk of PPCs and to identify adults who might benefit from respiratory rehabilitation.ObjectivesOur primary objective was to assess the effectiveness of preoperative inspiratory muscle training (IMT) on PPCs in adults undergoing cardiac or major abdominal surgery. We looked at all-cause mortality and adverse events.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to October 2014), EMBASE (1980 to October 2014), CINAHL (1982 to October 2014), LILACS (1982 to October 2014), and ISI Web of Science (1985 to October 2014). We did not impose any language restrictions.Selection criteriaWe included randomized controlled trials that compared preoperative IMT and usual preoperative care for adults undergoing cardiac or major abdominal surgery.Data collection and analysisTwo or more review authors independently identified studies, assessed trial quality, and extracted data. We extracted the following information: study characteristics, participant characteristics, intervention details, and outcome measures. We contacted study authors for additional information in order to identify any unpublished data.Main resultsWe included 12 trials with 695 participants; five trials included participants awaiting elective cardiac surgery and seven trials included participants awaiting elective major abdominal surgery. All trials contained at least one domain judged to be at high or unclear risk of bias. Of greatest concern was the risk of bias associated with inadequate blinding, as it was impossible to blind participants due to the nature of the study designs. We could pool postoperative atelectasis in seven trials (443 participants) and postoperative pneumonia in 11 trials (675 participants) in a meta-analysis. Preoperative IMT was associated with a reduction of postoperative atelectasis and pneumonia, compared with usual care or non-exercise intervention (respectively; risk ratio (RR) 0.53, 95% confidence interval (CI) 0.34 to 0.82 and RR 0.45, 95% CI 0.26 to 0.77). We could pool all-cause mortality within postoperative period in seven trials (431 participants) in a meta-analysis. However, the effect of IMT on all-cause postoperative mortality is uncertain (RR 0.40, 95% CI 0.04 to 4.23). Eight trials reported the incidence of adverse events caused by IMT. All of these trials reported that there were no adverse events in both groups. We could pool the mean duration of hospital stay in six trials (424 participants) in a meta-analysis. Preoperative IMT was associated with reduced length of hospital stay (MD -1.33, 95% CI -2.53 to -0.13). According to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group guidelines for evaluating the impact of healthcare interventions, the overall quality of studies for the incidence of pneumonia was moderate, whereas the overall quality of studies for the incidence of atelectasis, all-cause postoperative death, adverse events, and duration of hospital stay was low or very low.Authors' conclusionsWe found evidence that preoperative IMT was associated with a reduction of postoperative atelectasis, pneumonia, and duration of hospital stay in adults undergoing cardiac and major abdominal surgery. The potential for overestimation of treatment effect due to lack of adequate blinding, small-study effects, and publication bias needs to be considered when interpreting the present findings.

Project description:IntroductionOur institution implemented a preoperative protocol to identify high-risk cases for which power morcellation should be avoided.Material and methodsIn this retrospective cohort study, an institutional protocol requiring preoperative Magnetic Resonance Imaging with diffusion-weighted imaging and serum Lactate Dehydrogenase levels was implemented. Chart review was performed including all women who underwent intra-abdominal surgery for symptomatic fibroids from 4/23/2013 to 4/23/2015.ResultsA total of 1,085 women were included, 479 before and 606 after implementation of the Magnetic Resonance Imaging / Lactate Dehydrogenase protocol. The pre-protocol group had more post-menopausal women (4% vs. 2%, p = 0.022) and women using tamoxifen (2% vs. 0%, p = 0.022) than those in the post-protocol group, but baseline patient characteristics were otherwise similar between groups. Incidence of malignant pathological diagnoses did not change significantly over the time period in relation to protocol implementation. The rate of open surgery for both hysterectomy and myomectomy remained the same in the year preceding and the year following initiation of the protocol (open hysterectomy rate was 19% vs. 16% in pre- and post-protocol groups, respectively, P = 0.463, and open myomectomy rate was 10% vs. 9% rates in pre- and post-protocol groups, respectively, P = 0.776). There was a significant decrease in the use of power morcellation (66% in pre- and 50% in post-protocol cohorts, p<0.001) and an increased use of containment bags (1% in pre- and 19% in post-protocol cohort). When analyzing the subset of women who had abnormal Magnetic Resonance Imaging / and Lactate Dehydrogenase results, abnormal Magnetic Resonance Imaging results alone resulted in higher rates of open approach (65% for abnormal vs. 35% for normal). Similarly, a combination of abnormal Magnetic Resonance Imaging and Lactate Dehydrogenase tests resulted in higher rates of open approach (70% for abnormal and 17% for normal). Abnormal Lactate Dehydrogenase results alone did not influence route.ConclusionsRates of MIS procedures were decreased for women with abnormal preoperative Magnetic Resonance Imaging results. False positive results appear to be one of the main drivers for the use of an open surgical route.

Project description:BackgroundHip fracture is one of the most common orthopedic causes of hospital admission in frail elderly patients. Hip fracture fixation in this class of patients is considered a high-risk procedure. Preoperative physical examination, plasma natriuretic peptide levels (BNP, Pro-BNP), and cardiovascular scoring systems (ASA-PS, RCRI, NSQIP-MICA) have all been demonstrated to underestimate the risk of postoperative complications. We designed a prospective multicenter observational study to assess whether preoperative lung ultrasound examination can predict better postoperative events thanks to the additional information they provide in the form of "indirect" and "direct" cardiac and pulmonary lung ultrasound signs.MethodsLUSHIP is an Italian multicenter prospective observational study. Patients will be recruited on a nation-wide scale in the 12 participating centers. Patients aged > 65 years undergoing spinal anesthesia for hip fracture fixation will be enrolled. A lung ultrasound score (LUS) will be generated based on the examination of six areas of each lung and ascribing to each area one of the four recognized aeration patterns-each of which is assigned a subscore of 0, 1, 2, or 3. Thus, the total score will have the potential to range from a minimum of 0 to a maximum of 36. The association between 30-day postoperative complications of cardiac and/or pulmonary origin and the overall mortality will be studied. Considering the fact that cardiac complications in patients undergoing hip surgery occur in approx. 30% of cases, to achieve 80% statistical power, we will need a sample size of 877 patients considering a relative risk of 1.5.ConclusionsLung ultrasound (LU), as a tool within the anesthesiologist's armamentarium, is becoming increasingly widespread, and its use in the preoperative setting is also starting to become more common. Should the study demonstrate the ability of LU to predict postoperative cardiac and pulmonary complications in hip fracture patients, a randomized clinical trial will be designed with the scope of improving patient outcome. Trial registration ClinicalTrials.gov, NCT04074876. Registered on August 30, 2019.

Project description:BACKGROUND:Major abdominal surgery (MAS) is associated with increased morbidity and mortality. The main objective of our study was to evaluate the predictive value of heart-rate variability (HRV) concerning development of postoperative complications in patients undergoing MAS. The secondary objectives were to identify the relationship of HRV and use of vasoactive drugs during anesthesia, intensive care unit length of stay (ICU-LOS), and hospital length of stay (H-LOS). PATIENTS AND METHODS:Sixty-five patients scheduled for elective MAS were enrolled in a prospective, single-center, observational study. HRV was measured by spectral analysis (SA) preoperatively during orthostatic load. Patients were divided according to cardiac autonomic reactivity (CAR; n=23) and non-cardiac autonomic reactivity (NCAR; n=30). RESULTS:The final analysis included 53 patients. No significant difference was observed between the two groups regarding type of surgery, use of minimally invasive techniques or epidural catheter, duration of surgery and anesthesia, or the amount of fluid administered intraoperatively. The NCAR group had significantly greater intraoperative blood loss than the CAR group (541.7±541.9 mL vs 269.6±174.3 mL, p<0.05). In the NCAR group, vasoactive drugs were used during anesthesia more frequently (n=21 vs n=4; p<0.001), and more patients had at least one postoperative complication compared to the CAR group (n=19 vs n=4; p<0.01). Furthermore, the NCAR group had more serious complications (Clavien-Dindo ? Grade III n=6 vs n=0; p<0.05) and a greater number of complications than the CAR group (n=57 vs n=5; p<0.001). Significant differences were found for two specific subgroups of complications: hypotension requiring vasoactive drugs (NCAR: n=10 vs CAR: n=0; p<0.01) and ileus (NCAR: n=11 vs CAR: n=2; p<0.05). Moreover, significant differences were found in the ICU-LOS (NCAR: 5.7±3.5 days vs CAR: 2.6±0.7 days; p<0.0001) and H-LOS (NCAR: 12.2±5.6 days vs CAR: 7.2±1.7 days; p<0.0001). CONCLUSION:Preoperative HRV assessment during orthostatic load is objective and useful for identifying patients with low autonomic physiological reserves and high risk of poor post-operative course.

Project description:BackgroundPreoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.MethodsIn a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.FindingsOf 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.InterpretationPreoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery.FundingUK National Institute of Health Research Health Technology Assessment Program.

Project description:Low-risk elective surgical procedures are common, but there are no clear guidelines for when preoperative consultations are required. Such consultations may therefore represent a substantial discretionary service.To assess temporal trends, explanatory factors, and geographic variation for preoperative consultation in Medicare beneficiaries undergoing cataract surgery, a common low-risk elective procedure.Cohort study using a 5% national random sample of Medicare part B claims data including a cohort of 556,637 patients 66 years or older who underwent cataract surgery from 1995 to 2006. Temporal trends in consultations were evaluated within this entire cohort, whereas explanatory factors and geographic variation were evaluated within the 89,817 individuals who underwent surgery from 2005 to 2006.Separately billed preoperative consultations (performed by family practitioners, general internists, pulmonologists, endocrinologists, cardiologists, nurse practitioners, or anesthesiologists) within 42 days before index surgery.The frequency of preoperative consultations increased from 11.3% in 1998 to 18.4% in 2006. Among individuals who underwent surgery in 2005 to 2006, hierarchical logistic regression modeling found several factors to be associated with preoperative consultation, including increased age (75-84 years vs 66-74 years: adjusted odds ratio [AOR], 1.09 [95% CI, 1.04-1.13]), race (African American race vs other: AOR, 0.71 [95% CI, 0.65-0.78]), urban residence (urban residence vs isolated rural town: AOR, 1.64 [95% CI, 1.49-1.81]), facility type (outpatient hospital vs ambulatory surgical facility: AOR, 1.10 [95% CI, 1.05-1.15]), anesthesia provider (anesthesiologist vs non-medically directed nurse anesthetist: AOR, 1.16 [95% CI, 1.10-1.24), and geographic region (Northeast vs South: AOR, 3.09 [95% CI, 2.33-4.10]). The burden of comorbidity was associated with consultation, but the effect size was small (<10%). Variation in frequency of consultation across hospital referral regions was substantial (median [range], 12% [0-69%]), even after accounting for differences in patient-level, anesthesia provider-level, and facility-level characteristics.Between 1995 and 2006, the frequency of preoperative consultation for cataract surgery increased substantially. Referrals for consultation seem to be primarily driven by nonmedical factors, with substantial geographic variation.

Dataset Information

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

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Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

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